Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

818

Participants

Timeline

Start Date

April 16, 2020

Primary Completion Date

August 15, 2022

Study Completion Date

June 7, 2024

Conditions
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Interventions
DRUG

Fulvestrant

Patients will be administered 500 mg (2 injections) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter

DRUG

Capivasertib

400 mg BD (2 tablets of 200 mg taken twice a day = total daily dose 800 mg) given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle

DRUG

Placebo

Placebo to match 400 mg BD (2 tablets of placebo to match 200 mg taken twice daily = placebo to match total daily dose of 800 mg) given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle

Trial Locations (215)

333

Research Site, Taoyuan District

710

Research Site, Tainan City

1090

Research Site, Brussels

1122

Research Site, Budapest

1134

Research Site, Budapest

1200

Research Site, Brussels

2060

Research Site, North Sydney

2139

Research Site, Concord

2298

Research Site, Waratah

2610

Research Site, Wilrijk

2650

Research Site, Edegem

2800

Research Site, Orange

3128

Research Site, Box Hill

3135

Research Site, Ringwood East

3350

Research Site, Ballarat

3355

Research Site, Wendouree

4032

Research Site, Debrecen

4101

Research Site, South Brisbane

4575

Research Site, Birtinya

5000

Research Site, Adelaide

Research Site, Namur

Research Site, Szolnok

5037

Research Site, Kurralta Park

5300

Research Site, La Rioja

6000

Research Site, Charleroi

Research Site, Kecskemét

7100

Research Site, Szekszárd

8003

Research Site, Barcelona

8308

Research Site, Seoul

10002

Research Site, Taipei

10011

Research Site, New York

10060

Research Site, Candiolo

10408

Research Site, Goyang-si

11042

Research Site, Lake Success

11217

Research Site, Taipei

11259

Research Site, Taipei

13620

Research Site, Seongnam-si

14004

Research Site, Córdoba

14467

Research Site, Potsdam

15009

Research Site, A Coruña

15706

Research Site, Santiago de Compostela

16247

Research Site, Suwon

16499

Research Site, Suwon

20141

Research Site, Milan

20246

Research Site, Hamburg

20249

Research Site, Hamburg

20357

Research Site, Hamburg

21201

Research Site, Baltimore

22190

Research Site, Plerin SUR MER

22332

Research Site, Incheon

23007

Research Site, Jaén

23114

Research Site, Midlothian

24105

Research Site, Kiel

24127

Research Site, Bergamo

25000

Research Site, Besançon

25198

Research Site, Lleida

27403

Research Site, Greensboro

28007

Research Site, Madrid

28033

Research Site, Madrid

28034

Research Site, Madrid

28040

Research Site, Madrid

28041

Research Site, Madrid

28046

Research Site, Madrid

28222

Research Site, Majadahonda

29010

Research Site, Málaga

29609

Research Site, Brest

30625

Research Site, Hanover

31008

Research Site, Pamplona

31059

Research Site, Toulouse

31096

Research Site, Haifa

32224

Research Site, Jacksonville

32429

Research Site, Minden

33161

Research Site, Paderborn

33905

Research Site, Fort Myers

37211

Research Site, Nashville

37404

Research Site, Chattanooga

38320

Research Site, La Laguna (Tenerife)

40447

Research Site, Taichung

41013

Research Site, Seville

41124

Research Site, Modena

41931

Research Site, Daegu

43204

Research Site, Reus,Tarragona

45130

Research Site, Essen

45879

Research Site, Gelsenkirchen

46009

Research Site, Valencia

46010

Research Site, Valencia

47014

Research Site, Meldola

48149

Research Site, Münster

49100

Research Site, Petah Tikva

49241

Research Site, Busan

52621

Research Site, Ramat Gan

55905

Research Site, Rochester

57085

Research Site, Metz

57124

Research Site, Livorno

59100

Research Site, Prato

60389

Research Site, Frankfurt

62100

Research Site, Macerata

63156

Research Site, St Louis

64132

Research Site, Kansas City

66205

Research Site, Westwood

67065

Research Site, Strasbourg

68167

Research Site, Mannheim

69120

Research Site, Heidelberg

69310

Research Site, Pierre-Bénite

70403

Research Site, Tainan City

74374

Research Site, Pringy

75246

Research Site, Dallas

76038

Research Site, Rouen

80131

Research Site, Napoli

80637

Research Site, München

81377

Research Site, München

82445

Research Site, Kaohsiung City

84101

Research Site, Beersheba

85234

Research Site, Gilbert

87401

Research Site, Farmington

88100

Research Site, Catanzaro

90603

Research Site, Whittier

91031

Research Site, Jerusalem

91054

Research Site, Erlangen

91120

Research Site, Jerusalem

92868

Research Site, Orange

94143

Research Site, San Francisco

98373

Research Site, Puyallup

100044

Research Site, Beijing

100191

Research Site, Beijing

110001

Research Site, Shenyang

110042

Research Site, Shenyang

111123

Research Site, Moscow

115478

Research Site, Moscow

116011

Research Site, Dalian

130021

Research Site, Changchun

150081

Research Site, Harbin

197758

Research Site, Saint Petersburg

198255

Research Site, Saint Petersburg

200032

Research Site, Shanghai

200127

Research Site, Shanghai

226001

Research Site, Nantong

230001

Research Site, Hefei

230022

Research Site, Hefei

250001

Research Site, Jinan

276000

Research Site, Linyi

310003

Research Site, Hangzhou

310020

Research Site, Hangzhou

310022

Research Site, Gongshu District

330009

Research Site, Nanchang

354000

Research Site, Sochi

400030

Research Site, Chongqing

400042

Research Site, Chongqing

430022

Research Site, Wuhan

430030

Research Site, Wuhan

430079

Research Site, Wuhan

443031

Research Site, Samara

450008

Research Site, Zhengzhou

510080

Research Site, Guangzhou

510095

Research Site, Guangzhou

528000

Research Site, Foshan

641000

Research Site, Neijiang

1834111

Research Site, Afula

4428164

Research Site, Kfar Saba

02111-1520

Research Site, Boston

07652

Research Site, Paramus

B1884BBF

Research Site, Berazategui

C1125ABD

Research Site, Ciudad Autonoma de Buenos Aire

S2000KZE

Research Site, Rosario

R8500ACE

Research Site, Viedma

R3E 0V9

Research Site, Winnipeg

K7L 2V7

Research Site, Kingston

M2K 1E1

Research Site, North York

M3M 0B2

Research Site, Toronto

M4N 3M5

Research Site, Toronto

071000

Research Site, Baoding

CN-515031

Research Site, Shantou

01307

Research Site, Dresden

00128

Research Site, Roma

260-8717

Research Site, Chiba

811-1395

Research Site, Fukuoka

960-1295

Research Site, Fukushima

350-1298

Research Site, Hidaka-shi

730-8518

Research Site, Hiroshima

892-0833

Research Site, Kagoshima

362-0806

Research Site, Kitaadachi-gun

135-8550

Research Site, Kōtoku

860-8556

Research Site, Kumamoto

606-8507

Research Site, Kyoto

791-0280

Research Site, Matsuyama

464-8681

Research Site, Nagoya

467-0001

Research Site, Nagoya

540-0006

Research Site, Osaka

541-8567

Research Site, Osaka

373-8550

Research Site, Ota-shi

003-0804

Research Site, Sapporo

060-8638

Research Site, Sapporo

142-8666

Research Site, Shinagawa-ku

514-8507

Research Site, Tsu

241-8515

Research Site, Yokohama

AREQUIPA01

Research Site, Arequipa

LIMA 41

Research Site, Lima

85-796

Research Site, Bydgoszcz

31-501

Research Site, Krakow

10-228

Research Site, Olsztyn

02-781

Research Site, Warsaw

03722

Research Site, Seoul

05505

Research Site, Seoul

135-710

Research Site, Seoul

08035

Research Site, Barcelona

08907

Research Site, Hosp de Llobregat(Barcelona)

AB25 2ZN

Research Site, Aberdeen

BH7 7DW

Research Site, Bournemouth

BS2 8ED

Research Site, Bristol

CF14 2TL

Research Site, Cardiff

GL53 7AN

Research Site, Cheltenham

NW3 2QG

Research Site, London

SW3 6JJ

Research Site, London

M20 4GJ

Research Site, Manchester

SM25PT

Research Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY